A $10 million allergy case: Could it happen to you?

Warning your patients about the dangers of food allergies may save their lives. Not warning them can cost you—big-time.

By Berkeley Rice
Senior Editor

Every primary care physician should be aware of the importance of warning patients who have food allergies about the risk of anaphylactic shock. In fact, failing to issue such warnings can get you sued for malpractice. That's what happened to three pediatricians and an allergist in New Brunswick, NJ. Earlier this year, jurors found the allergist and one of the pediatricians liable for $10 million because a patient suffered severe brain damage after eating a peanut-laden candy.

Ray Varghese was 2 when he developed a facial rash and swelling after eating peanut "M&M's." His parents took him to their pediatrician, Ramalakshmi Yerramilli. She prescribed an over-the-counter antihistamine, according to the lawsuit, but didn't warn the Vargheses about the risk of a more severe allergic reaction.

Four years later, after eating a Reese's Peanut Butter Cup, Ray broke out in a rash over most of his body and had difficulty breathing. Yerramilli diagnosed an asthmatic condition and again prescribed an antihistamine. But as before, according to the suit, she didn't refer the boy to an allergist, didn't warn the family about the risk of anaphylactic shock (which had increased, due to the asthmatic condition), and never prescribed epinephrine as protection against it.

Some time after that incident, the Vargheses changed health plans and switched to a different pediatric group. Ray saw two pediatricians there, Subrahmanyam Ganti and Vijaya Radhakrishna. When those doctors learned of Ray's peanut allergy and asthma, they referred him to allergist Alan Okie. Neither those pediatricians nor Okie, the suit asserted, warned the Vargheses of the potential danger of Ray's allergy or prescribed epinephrine.

In 1996, the Vargheses switched plans again and returned to Yerramilli. On Christmas Day of that year, Ray, then 7, ate some candy from a gift box of assorted chocolates, went into anaphylactic shock, and suffered respiratory and cardiac arrest. Now nearly 13, he's quadriplegic and in a permanent vegetative state.

Litigation follows the tragic incident

In 1999, the Vargheses filed a malpractice suit against Yerramilli and the other three physicians who had treated their son, claiming that they "knew or should have known" that his peanut allergy put him at risk for a severe and potentially fatal reaction.

Yerramilli settled the claim against her just before the case went to court, but the terms of the settlement remain confidential. At the trial, Ganti and Radhakrishna argued that they weren't responsible for the boy's injuries because their duty ended when they referred him to Okie, the allergist. Ganti and Radhakrishna filed a countersuit against the Vargheses, claiming that they had been told what might happen if their son ate foods containing peanuts, and should have prevented him from doing so. In court, however, the Vargheses testified that they had tried to prevent Ray's exposure to peanuts, but hadn't been sufficiently warned about the danger of anaphylactic shock. "Anaphylaxis is a quick and sudden allergic reaction that is life-threatening," said their attorney, Steven Blader. "That word was never heard by the Vargheses. The doctors should have warned them."

A wake-up call for physicians

According to James Rosen, a West Hartford, CT, allergist who testified as a plaintiffs' expert in the case, it's "appropriate, but not essential" to refer patients with food allergies to an allergist for further testing. "If a primary care doctor does everything else right," says Rosen, "if he makes the correct diagnosis, educates the family about the potential risks, and prescribes epinephrine, that may be sufficient to meet the standard of care.

"But if the parents tell you their child had a reaction to peanuts, and all you do is tell them to avoid peanuts, that doesn't meet the standard of care. You have to develop a complete plan to help them prevent another reaction. That means educating them about avoiding all foods that might contain the dangerous ingredient. You have to tell them what to do if the child has a reaction, and you must prescribe epinephrine."

After a two-week trial, the jury awarded the Vargheses $10 million, attributing 80 percent of the liability to Yerramilli, 20 percent to Okie, and none to the other two pediatricians or the parents. Since Yerramilli had already settled, however, attorney Robert Ross, who represents Ray Varghese, has filed a motion urging the judge to order Okie to pay the entire $10 million. Ross has also appealed the jury's finding of nonliability on the part of the other two pediatricians.

Okie, now living in Florida, didn't appear at the trial and wasn't represented by a lawyer. According to Blader, the Vargheses' attorney, Okie has no malpractice insurance, which raises doubt about the likelihood of collecting such a huge judgment against him. (Okie did not respond to repeated requests for comment on this story.)

Ross claims that this case is one of the first in which a food allergy reaction has led to a plaintiff's verdict. The case is also significant, he says, because it represents a warning to primary care doctors that such allergies must be taken seriously. "You have to tell patients and their families that there's a real danger," says Ross. "Hopefully, word of this case will spread and will be a wake-up call for physicians."

What to do if your patient has a food allergy

Allergic reactions to foods can range from a mild rash to life-threatening respiratory and cardiovascular arrest. For that reason, early diagnosis, appropriate treatment, and patient education about avoiding the offending food and the proper response to anaphylaxis are crucial.

According to the The Food Allergy & Anaphylaxis Network of Fairfax, VA, about 2 percent of the population is allergic to foods such as peanuts, tree nuts (walnuts, pecans, etc.), eggs, wheat, milk, soy, fish, and shellfish. Food-induced anaphylaxis causes an estimated 30,000 trips to the ED and 150 to 200 deaths each year. Those who die, mostly children and young adults, usually know about their allergy but don't have epinephrine available at the time of the attack.

While a rash may suggest a food allergy, primary care physicians must take a thorough history because rashes may result from other causes. If the source of the reaction is unclear, the doctor should refer the patient to an allergist for testing. The danger is much greater if a child also has asthma, because that condition can mask the symptoms of anaphylaxis.

Once a child has been diagnosed with an allergy that puts him at risk for anaphylaxis, it's essential to prescribe self-injecting epinephrine. But even that's not enough, says Catherine Monteleone, director of the allergy and immun-ology department at UMDNJ-Robert Wood Johnson Medical School, in New Brunswick, NJ. "You have to teach patients how and when to use it." Even after an injection, patients should be rushed to the ED for monitoring in case a higher dose or other treatment is required.

Moreover, physicians should instruct parents to notify baby sitters, parents of playmates, and personnel at the child's school, day care facility, or camp about the risk of a severe reaction, says Monteleone. Those people should also be provided with epinephrine and instructions in how to administer it. As an added precaution, children at risk for anaphylaxis should wear a medical ID bracelet.

Teaching the child to avoid specific foods is essential. So is constant vigilance. "Parents need to read all packaged food labels and question waiters at restaurants," says Monteleone.

Although lawsuits based on failure to diagnose or treat food allergies are rare, some malpractice insurance carriers now cover the topic in their risk management seminars for physicians. One clear message: You can't afford to ignore or underestimate the potential danger of anaphylaxis.

David Karp, a risk management consultant based in Cloverdale, CA, recommends that all physicians "take each patient's allergy history at least once a year, because people develop new allergies over time, even to foods they've previously eaten without a problem." In fact, Karp adds, "it doesn't hurt to ask about allergic reactions at each visit, particularly for patients with known allergies. It's important to document that information, and each patient's chart should have a clearly visible sticker on it listing food and drug allergies."

For more information, contact The Food Allergy & Anaphylaxis Network at 10400 Eaton Place, Suite 107, Fairfax VA 22030, or www.foodallergy.org , or call 800-929-4040.

 

Berkeley Rice. A $10 million allergy case: Could it happen to you?. Medical Economics 2002;11:36.